Tests CAR-T cell therapy for myeloma returning after a donor stem cell transplant
Tests CARTemis-1 cells in adults with myeloma relapsing after a donor transplant.
Plain-language title generated from the registry record
Registry title: Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant
Key facts
- Where
- Barcelona, Salamanca, Santander, Sevilla, and Valencia, SpainSee the 5 sites
- Phase
- Phase 1/2
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Trial code
- NCT05982275EU 2022-503063-15-00
- Record updated
- 14 May 2024
- Original description
Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.Read full original descriptionShow less
Anti-BCMA Chimeric Antigen Receptor (CARTemis-1) T-lymphocyte Therapy in the Treatment of Patients With Multiple Myeloma in Relapse After Allogeneic Transplant: Endothelial Growth Factor Receptor Expression as a Control Mechanism of Treatment-derived Complications
Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.
Inclusion: Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma; Measurable disease at the time of screening; Previous treatment with ≥2 lines before and/or after allogeneic transplant; Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease; Eastern Cooperative Oncology Group functional status from 0 to 1; Life expectancy greater than 3 months (at the time of screening); Patients who give their consent by signing the Informed Consent document.
Exclusion: Patients who have previously received treatment with CAR-T Anti-BCMA; Previous neoplasm, except if it has been in complete remission >3 years, with the exception of skin carcinoma (non-melanoma); Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome; Contraindication to receive lymphodepleting chemotherapy; Active infection requiring treatment; Active HIV, hepatitis B virus or hepatitis C virus infection; Uncontrolled medical illness; Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused; Absolute lymphocyte count <0.2x109/L; Severe organic disease that meets any of the following criteria: left ventricular ejection fraction <40%, carbon monoxide diffusion test <40%, glomerular filtration rate <50 ml/min, bilirubin >3 normal value (except Gilbert syndrome); Women of childbearing age, unable or unwilling to use highly effective contraceptive methods; Men who cannot or do not wish to use highly effective contraceptive methods. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period; Active systemic immunosuppressive treatment; Pregnant or lactating women.